Amgen Senior Associate Regulatory Affairs (1 Year Contract) in Mississauga, Ontario

Role: Sr. Associate, Regulatory Affairs

Location: Mississauga Head Office

Reports to: Director, Regulatory Affairs

The Sr. Associate, under the direction of a Sr. Manager or Manager performs:

Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements

Execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions

Coordination and execution of Regulatory Affairs processes and deliverables in the local office.

Regional Specific Activities

Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements

Contribute to and execute the filing plan for their country where applicable

Review source text for country labeling

Review promotion and non-promotion materials

Disseminate relevant information to team(s) as appropriate

Participate in local regulatory process improvements initiatives

Assist locally in Healthcare Compliance activities where applicable

Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner

Coordinating translation for local Regulatory submission

Collaboration

Collate, distribute and review Regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis

Partner with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules

HA Interaction

Under general supervision interact with local health and regulatory authorities for routine matters

Basic Qualifications

Master's degree

OR

Bachelor's degree and 4 years of regulatory experience

OR

Associate's degree and 6 years of regulatory experience

OR

High school diploma / GED and 8 years of regulatory experience

Preferred Qualifications

Knowledge and Skills

Regulatory principles

Working with policies, procedures and SOP's

Knowledge of national legislation and regulations relating to medicinal products

Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals

Knowledge of drug development

Scientific / Technical Excellence

Team work

Communication skills - both oral and written

Ability to understand and communicate scientific/clinical information

Ability to anticipate and prevent potential issues

Knowledge of and experience in regional regulatory environment in relevant product area and development stage

Understanding of regulatory activities and their touch points

Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

Cultural awareness and sensitivity to achieve results across both regional country and International borders

Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact staffing@amgen.com to make a request and ensure you include the requisition number.

Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview